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510(k) Data Aggregation
(189 days)
It is intended for use for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs. Not suitable for use for observation and treatment of the heart and must not contact the heart or its vicinity.
The SIRIUS Endoscope System as a robotic endoscope consists of Video Processor, Laparoscope Handle, Laparoscope Head and Joystick. The SIRIUS Endoscope System is developed for minimal invasive surgery application. The SIRIUS Endoscope System is a fully integrated compact 3D laparoscopic camera system with a flexible tip that can change its viewing direction. The Laparoscope Head is made of biocompatible materials. The articulated tip has three degrees of freedom enabling C and S shaped bending. The insertion is 10 mm diameter and 340 mm working length. Stereo camera with 1080 high-definition resolution. It has 120 degrees field of view, 10-100mm depth of view and bright light with 300 lumen.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criterion (if available) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meets ISO 10993 standards | Complies with ISO 10993-1, -5, -10, -11 requirements (Cytotoxicity, Sensitization, Irritation, Acute systemic toxicity, Pyrogen testing performed). |
| Sterility | Sterility Assurance Level 10^-6 | Validated via Ethylene Oxide (EO) sterilization per ISO 11135:2014 overkill half-cycle approach. EO and chlorohydrin residuals within ISO 10993-7 limits. |
| Electrical Safety and EMC | Complies with IEC 60601 standards | Complies with IEC 60601-1, IEC 60601-2-18 (safety) and IEC 60601-1-2 (EMC). |
| Light Source Safety | Complies with IEC 62471 | Lamp certified as Risk group 2 and complies with IEC 62471:2006. |
| Software Verification and Validation | Adherence to FDA Guidance | Software Verification and Validation Testing conducted as per FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software considered "Moderate" level of concern. |
| Usability Evaluation | Adherence to ANSI AAMI IEC 62366-1 | Conducted per ANSI AAMI IEC 62366-1:2015+AMD1:2020. Usability testing and improvement actions minimized residual risk. |
| Performance Testing (Endoscope Standards) | Meets ISO 8600-1 | Complies with ISO 8600-1:2015. |
| Meets ISO 8600-3 | Complies with ISO 8600-3:2019 (determination of field of view and direction of view). | |
| Meets ISO 8600-4 | Complies with ISO 8600-4:2014 (determination of maximum width of insertion portion). | |
| Meets ISO 8600-7 | Complies with ISO 8600-7:2012 (basic requirements for water-resistant medical endoscopes). | |
| Tip Articulation | Meets ISO 8600-1:2015 requirements | Angle of deflection for ±90° up-down and ±45° left-right joints meet the requirement of ISO 8600-1:2015. |
| Shaft Material Compatibility | Biocompatible | Different materials from predicate, but both are biocompatible, and biocompatibility tests demonstrated safety. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes bench testing and compliance to international standards. It does not specify "test sets" in the context of patient data or clinical trials with specific sample sizes. The data provenance is not mentioned beyond the manufacturer being in Hong Kong. The testing appears to be primarily laboratory-based (bench testing) rather than clinical studies using patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The document focuses on technical and regulatory compliance testing rather than expert-derived ground truth from clinical cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as the studies described are not clinical studies requiring adjudication of diagnostic outcomes.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of an MRMC comparative effectiveness study, AI assistance, or human reader improvement. The device described is an endoscope system, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
There is no mention of an algorithm-only standalone performance study. The device is hardware (an endoscope system) with associated software, but not an AI algorithm performing diagnostic tasks independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance testing, the "ground truth" is adherence to international standards (e.g., ISO 8600 series) and published specifications. For biocompatibility, sterility, electrical safety, etc., the ground truth is defined by the requirements of the respective international standards (e.g., ISO 10993, ISO 11135, IEC 60601, IEC 62471).
8. The sample size for the training set
This information is not applicable or not provided. The device is an endoscope system, and the testing described is not related to machine learning model training.
9. How the ground truth for the training set was established
This information is not applicable or not provided for the same reasons as above.
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